Evaluated the Efficacy and Safety of APCP on Hair Health

Hair Damage Clinical Trial

Official title:

A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06422026
• Other study ID #: AP-PV-2022-02
• Status: Completed
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors

• A person capable of maintaining the same hair shape and color during this human body application test

• A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

Exclusion Criteria:

• A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc

• As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection

• A person who plans to manage and operate hair supplies, hair products during this human body application test

• A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1

• A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1

• Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)

• A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1

• A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test

• A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test

• A person who is sensitive to or allergic to food ingredients for this human body application test

• A person who is deemed inappropriate by the tester for other reasons

Related Conditions & MeSH terms

• Hair Damage

Intervention

Dietary Supplement:
• APCP I
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.
• APCP II
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.
• Placebo
Each subject takes one active bottle per day for 24 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hair tensile strength	Hair tensile strength measured by UTM(Universal Testing Machine) etc.	Baseline, 24 week
Secondary	Change from baseline in hair gloss	Hair gloss measured by Glossymeter etc.	Baseline, 24 week
Secondary	Change from baseline in hair density	Hair density measured by Folliscope	Baseline, 24 week
Secondary	Change from baseline in hair volume	Hair volume measured by I Max-plus	Baseline, 24 week
Secondary	Change from baseline in satisfaction survey	Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question).	Baseline, 24 week
Secondary	Change from baseline in scalp moisture	scalp moisture measured by DermaLab Hydration Pin Probe	Baseline, 24 week
Secondary	Change from baseline in scalp percutaneous moisture loss	scalp percutaneous moisture loss measured by Tewameter TM Nano	Baseline, 24 week